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Tuesday, March 20, 2018

I feel like a broken record, but I am going to talk about another error in the MAUDE database.

For those playing along at home, the FDA tracks medical device malfunctions and adverse events using a database known as MAUDE. They are nice enough to make the entire database available for download. You can download the data files here. Last week, I noticed that one of the data files was missing reports from January 2018.

I emailed them informing them of the error.

They emailed me back explaining that everything was fine.

I emailed them back, explaining that it wasn't.

They emailed me back (see pic below) and fixed the issue.

I don't know how/why these errors keep cropping up, but it's the 3rd error I've found in MAUDE over the past year.

Friday, March 9, 2018

The FDA uses a data-base/search engine known as MAUDE to monitor the safety and malfunctions of FDA approved medical devices.

A few days ago, I downloaded the FDA's MAUDE "raw" data-set (located here). I do this a few times per month, and today I noticed that at least part of the data-set is corrupt. I won't go into the gory details, but some of the 2018 data seems to have been mistakenly vaporized from the current data-set.

While, I was trying to figure out what was corrupted, I ran a test search using the FDA's MAUDE search-engine (located here).

I searched for the word veritas and I got ZERO results.

Now, I KNOW there are reports in MAUDE involving the veritas collagen matrix because I've run the search before, so when I got ZERO results, I knew that not only were the "raw" data-files corrupt, but something was also corrupt with the FDA's live search-engine.

As I was writing my email to the FDA, I started to tell them that their error was NOT ONLY with the "raw" data-set, but their search-engine was corrupted, too!

Then I decided that I should take a screenshot of my search results just in case they thought I was crazy.

So, I re-ran the veritas search.

But this time, when I ran it, I got 62 RESULTS! See pic below. I started to think, "Maybe I amgoing crazy. Maybe I punched in the wrong search term, or maybe I selected an incorrect parameter."

But then, I ran the search again (2 minutes later), and I got 64RESULTS!

Approximately 1 hour later, and we are up to 145 results.

So...just in case this is confusing....

The FDA is correcting errors on its production database.

In the middle of the day.

On a Friday.

And they're doing all of this while the search-engine is LIVE.

I can tell because I'm watching it happen in real time.

To the database and software-dev people out there, that is some cowboy stuff.